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Supplement Reform Appears Dead for 2022: Report

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Republican Sen. Richard Burr says the lame-duck session of Congress will not consider reforming FDA oversight of dietary supplemen...

Staley Debarred for 5 Years

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Federal Register notice: FDA issues an order debarring Jennings Ryan Staley for five years from importing or offering for import a...

Caribou Bio Wins 2 Designations from FDA

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FDA grants Caribou Biosciences a Regenerative Medicine Advanced Therapy designation for CB-010 and its use in treating relapsed or...

Panel to Discuss Cidara Therapeutics Rezafungin NDA

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Federal Register notice: FDA announces a 1/24 Antimicrobial Drugs Advisory Committee meeting to vote on Cidara Therapeutics NDA fo...

Device Advisory Panels Need Voting Members: FDA

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Federal Register notice: FDA seeks nominations for voting members to serve on the Medical Devices Advisory Committee device panels...

Sarepta BLA for Duchenne Muscular Dystrophy

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FDA accepts for review a Sarepta Therapeutics BLA that is seeking accelerated approval for SRP-9001 (delandistrogene moxeparvovec)...

NeuroLogica BodyTom CT Scanner Cleared by FDA

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FDA clears a NeuroLogica 510(k) for its BodyTom 64 Point-of-Care Mobile Computed Tomography Scanner.

Enforcement Guide on Fecal Microbiota for Transplantation

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FDA releases a final guidance entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbi...

No REMS Needed for Gene Therapy: FDA

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FDA denies a petition seeking Risk Evaluation and Mitigation Strategiesfor Behrings simultaneously approved Hemophilia B gene ther...

Device Color Additive Risk Calculator Qualified

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CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.